FDA proposes to ban certain shock devices for the second time
The health regulator said these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.
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The health regulator said these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.
A consistent theme from SXSW is the downturn of brand advertising. Consumers don’t want to feel marketed to but are open to content that is entertaining or provides some value exchange. Value is not a new concept, as content marketing has been a consistent tactic for a long time. But more often we see consumers’ ability to block or tune out brand content. Couple this with the fact that content looks much different than it did even a few years ago, and it’s clear that this is an area where pharma needs to innovate.
AbbVie Inc. and Landos Biopharma, Inc. today announced a definitive agreement under which AbbVie will acquire Landos, a clinical stage biopharmaceutical company focused on the development of novel, oral therapeutics for patients with autoimmune diseases. Landos’ lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist (a member of the NOD-like receptor family) with a bimodal mechanism of action (MOA), which is anti-inflammatory and facilitates epithelial repair.
Regeneron Pharmaceuticals said the U.S. FDA has declined approval for its blood cancer therapy for two forms of lymphoma, raising concerns over the progress of ongoing confirmatory trials.
The combo pill is indicated for chronic use in pulmonary arterial hypertension (PAH) patients falling under the World Health Organization’s functional classes II to III. These classes include patients who may have no symptoms at rest but experience shortness of breath or discomfort during normal activities such as climbing stairs or running errands.
Axsome Therapeutics said on Monday its experimental therapy cut the frequency of disruptive episodes of muscle weakness tied to a sleep disorder called narcolepsy in a late-stage trial.
The new offering will help life science and pharmaceutical brands create better and more personalized experiences for both diagnosed and undiagnosed patient populations, accelerating paths to diagnosis and treatment, and creating unmatched educational opportunities. Brand teams will gain unmatched insights into what patient communities are saying and looking for, and then serve up customized content to help them at any stage of the patient journey.
The full approval makes Elahere the “first and only antibody-drug conjugate (ADC) approved in the U.S. for” ovarian cancer, a “difficult-to-treat malignancy,” AbbVie CMO of global therapeutics Roopal Thakkar, said in a statement.
The U.S. National Institutes of Health has sent a notice to the German company regarding default on the payment of royalties and other amounts related to its COVID-19 vaccine.
Cardior is a leader in the discovery and development of therapies that target RNA as a means to prevent, repair and reverse diseases of the heart. The company’s therapeutic approach targets distinctive non-coding RNAs as a platform for addressing root causes of cardiac dysfunctions with an aim to achieve lasting patient impact.